An interventional study of Physical activity program and Control group standard care in Low Back Pain, Recurrent and Low Back Pain, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by McMaster University · Not applicable, Interventional, and Prevention
Among 82 studies in Low Back Pain with a site in Canada — 11 open to participants now, 12 under way, none of them phase 3. Low Back Pain · Canada.
Among the 82 studies in Low Back Pain with a site in Canada, this one is the 57th largest by enrollment of the 66 interventional ones that give a count, is one of 5 that started in 2018, is one of 52 with no phase, and was the 36th registered.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
Browse Low Back Pain studies →11 of the 82 studies in Low Back Pain with a site in Canada are open now. Recruiting first, the newest first:
Igor Wilderman. MD · Sites in Canada
University Health Network, Toronto · Sites in Canada
Laval University · Sites in Canada
Laval University · Sites in Canada
University of Alberta · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 333 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 211 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 6 · Phase 4 2
First in 2004; this study’s year is marked. 5 started in 2018.
This study's enrollment of 17 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Median enrollment 61 across the 66 interventional studies, 95 across the 16 observational. Of the 61 that completed or were terminated, 7 (11%) have results posted.
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13 of 82 have an industry lead sponsor. The 10 most frequent:
McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
McMaster University has 6 studies filed under Low Back Pain — fewer than ten, so there is no comparison to draw.
6 of the studies in Low Back Pain with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05929846McMaster UniversityBack to Living Well: Implementation of a Community-based Program for Low Back Pain | 2026-12-30 |
| NCT06924671University of AlbertaGLA:D Back Canada - a Program for Chronic and Persistent Low Back Pain | 2027-02 |
| NCT07614568Octane Innovation Inc.Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain | 2027-06 |
| NCT07696741University Health Network, TorontoPRT for Chronic Low Back Pain | 2027-06 |
| NCT05963451Université de SherbrookeBrain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain | 2027-07-16 |
Among the 82 studies in Low Back Pain with a site in Canada, from their registry updates:
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The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.
Secondary objectives are to:
Secondary objectives are to:
Exploratory objectives include:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will be included if they meet the following criteria
Exclusion criteria:
Participants will be excluded if they meet the following criteria:
The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..
Other: Physical activity program
Participants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.
Other: Control group standard care
This arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support.
Participants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity. Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement
Activity limiting flare-up
* flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year
Time frame: 12 months
Activity limiting flare-up
* flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year
Time frame: 3 and 6 months
Personal Impact of low back pain
the outcome combines 9 items from the Patient Reported Outcome Measurement Information System (PROMIS) short form and covers the domains of pain intensity, pain interference with normal activities and functional status widely recommended in consensus documents on outcome measures for back pain
Time frame: 3, 6, 12 months
Pain intensity _NRS pain
Pain intensity over the last week will be measured using a numeric rating scale 0-10 where 0 is not pain and 10 is worse pain
Time frame: 3, 6, 12 months
Disability
Roland Morris Disability Questionnaire is a scale from 0-24 assessing pain related disability where 0 is no disability and 24 is significant disability
Time frame: 3, 6, 12 months
Function
Patient Specific Functional Scale is a self reported scale assessing function on a scale from 0-10 where 0 is not able to perform the activity and 10 is able without pain
Time frame: 3, 6, 12 months
Health related Quality of Life: EQ-5D-5L
EQ-5D-5L
Time frame: 3, 6, 12 months (0-100)
Physical activity questionnaire
IPAQ_short form
Time frame: 3, 6, 12 months
Physical activity level
Activity level measured using Garmin physical activity monitor
Time frame: 3, 6, 12 months
Plan to share: No
Ran from Nov 2018 to primary completion in Dec 2019, 13 months.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 13 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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